Tranexamic Acid

What it is and how it works

Mechanism of Action Tranexamic acid is a synthetic lysine amino acid derivative, which diminishes the dissolution of hemostatic fibrin by plasmin. In the presence of tranexamic acid, the lysine receptor binding sites of plasmin for fibrin are occupied, preventing binding to fibrin monomers, thus preserving and stabilizing fibrin's matrix structure. The antifibrinolytic effects of tranexamic acid are mediated by reversible interactions at multiple binding sites within plasminogen. Native human plasminogen contains 4 to 5 lysine binding sites with low affinity for tranexamic acid (K d = 750 μmol/L) and 1 with high affinity (K d = 1.1 μmol/L).

Indications

Tranexamic Acid in Sodium Chloride Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic Acid in Sodium Chloride Injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction .

Dosage and administration (summary)

Before Extraction: Administer 10 mg/kg actual body weight of Tranexamic Acid in Sodium Chloride Injection intravenously with replacement therapy. After Extraction: Administer 10 mg/kg actual body weight 3 to 4 times daily for 2 to 8 days. Infuse no more than 10 mL/minute to avoid hypotension . Reduce the dosage for patients with renal impairment ( 2.2 , 8.6 ). Recommended Dosage The recommended dose of Tranexamic Acid in Sodium Chloride Injection is 10 mg/kg actual body weight intravenously administered as a single dose, immediately before tooth extractions. Infuse no more than 10 mL/minute to avoid hypotension .

Contraindications

Tranexamic Acid in Sodium Chloride Injection is contraindicated: In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients. In patients with active intravascular clotting . In patients with hypersensitivity to tranexamic acid or any of the ingredients . In patients with subarachnoid hemorrhage, due to risk of cerebral edema and cerebral infarction .

Warnings and precautions

Risk of Thrombosis with concomitant use of Factor IX: Avoid concomitant use . Seizures: Inadvertent injection into neuraxial system may result in seizures . Hypersensitivity Reactions: In case of severe reaction, discontinue use and seek immediate medical attention . Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur . Dizziness. Advise patients not to drive if dizziness occurs . Thromboembolic Risk Tranexamic Acid in Sodium Chloride Injection is contraindicated in patients with active intravascular clotting.

Pregnancy

Pregnancy Risk Summary Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes.

Storage and supply

Tranexamic Acid in Sodium Chloride Injection is a sterile, unpreserved, colorless solution in a single-dose polyolefin container with a polypropylene overwrap supplied as: Product Code Unit of Sale Strength Each 534110 NDC 65219-534-10 Unit of 24 1,000 mg per 100 mL (10 mg per mL) NDC 65219-534-01 100 mL free flex ® bag Discard any unused portion.

Source: Tranexamic Acid (Tranexamic Acid In Sodium Chloride) — US FDA prescribing information, 2025-01-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.